NCT07472530

Respiratory Exercises in Frail Elderly COPD Patients

The Effect of Respiratory Exercises on Frailty and Dyspnea in Geriatric Patients With Chronic Obstructive Pulmonary Disease: A Single-Blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Çankırı Karatekin University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

Purpose: This study evaluated the impact of a structured intervention on frailty, lung function, physical capacity, and dyspnea in elderly COPD patients. COPD, common in older adults, often coexists with frailty, which worsens health outcomes. While pulmonary rehabilitation improves function, its effect on frailty remains unclear. Procedures: A total of 66 patients with a confirmed diagnosis of COPD were randomly allocated into two equal groups: an intervention group (n=33) and a control group (n=33). Participants in the intervention group completed a six-week pulmonary rehabilitation program. Both baseline and post-intervention evaluations comprised spirometric measurements (FVC, FEV1, FEV1/FVC ratio, FEF25-75, and PEF), the Edmonton Frailty Scale (EFS), the six-minute walk test (6MWT), oxygen saturation levels, and assessments of dyspnea severity. Results: Significant improvements were observed in the intervention group in FVC, FEV1, FEV1/FVC, and PEF (p\<0.05). Total EFS scores and subdimensions such as mood, general health, and cognitive status also improved significantly (p\<0.05). Additionally, the intervention group showed increased 6MWT distance, higher oxygen saturation, and reduced dyspnea scores post-intervention (p\<0.05), with minimal changes in the control group. Conclusion: The findings suggest that pulmonary rehabilitation not only enhances pulmonary function and exercise capacity but also reduces frailty severity in elderly COPD patients. Integrating frailty-focused strategies into routine COPD management may improve outcomes and quality of life in this population.

Detailed description

This prospective, single-blind, randomized controlled study was conducted between August 2023 and October 2023. A total of 70 patients who presented to the Chest Diseases Outpatient Clinic of Çerkeş State Hospital were enrolled. T Following a one-month baseline assessment period, 32 patients who did not meet the inclusion criteria were excluded. Stratified randomization was employed to ensure equal assignment to groups based on age, sex, and COPD stage. Group allocations were determined using a computer-based program (random.org), randomly assigning 35 patients to the intervention group and 35 to the control group. Patients were blinded to their group assignments. Initially, pre-test data were collected from both the intervention and control groups using the measurement instruments prior to the commencement of the exercise program. Subsequently, the intervention group underwent an eight-week exercise program using an incentive spirometer (Triflow) provided by the researchers. Patients were each given the same brand and model of Triflow device (manufactured in Turkey). Practical training on the use of the Triflow was provided, and visual materials prepared by the researcher were given to the patients. Exercise training was administered to the patients in the Chest Diseases Outpatient Clinic by the second author. Patients were instructed to perform the exercise hourly, 10 times per repetition, after waking up at home. The breathing exercise program was evaluated weekly via telephone calls with the patients. No changes were made to the patients' inhaler treatments during the study period. During the study, one patient in the intervention group withdrew due to death, and another due to the initiation of treatment for pneumonia. A total of 33 patients completed the 8-week exercise program. No exercise regimen was applied to the control group; however, they were contacted regularly each week to inquire about any changes in their health status. Two patients in the control group were lost to follow-up, and therefore their post-test data could not be collected. At the conclusion of the exercise program, the measurement instruments were re-administered to 33 patients in the intervention group and 33 patients in the control group.Data Collection Instruments Data for the research were collected using the "Personal and Medical Characteristics Information Form" developed based on a literature review , along with the Six-Minute Walk Test , Modified Borg Dyspnea Scale , Pulmonary Function Test , and the Edmonton Frailty Scale. Statistical analyses were carried out using IBM SPSS Statistics version 26. Descriptive data were summarized by calculating means, standard deviations, frequencies, and percentages. The assumptions of normality were assessed through skewness and kurtosis values, with acceptable ranges set at ±1.5 to confirm normal distribution. To assess differences between the intervention and control groups before and after treatment, Independent Samples t-tests were employed. Changes within groups from pre- to post-intervention were evaluated using Paired Samples t-tests. Categorical data comparisons were conducted with Chi-square and Fisher's Exact tests, where appropriate. Statistical significance was set at p \< 0.05 for all analyses. Furthermore, A power analysis was conducted using the G\*Power 3.1.9.7 software package. Based on the study results, the effect size was calculated as 1.23. Accordingly, with a sample size of 66 participants (33 in the intervention group and 33 in the control group), the study achieved a statistical power of 99.84% at a significance level of α = 0.05. Ethical principles The authors affirm that all human subject experiments were performed in compliance with the Declaration of Helsinki, and that informed consent was obtained from all participants prior to the procedures. The study was approved by the "This area has been blinded" Ethics Committee (Number: "This area has been blinded"., Date: "This area has been blinded").

Conditions

• Fraility
• COPD (Chronic Obstructive Pulmonary Disease)
• Older Adults (65 Years and Older)

Interventions

Type	Name	Description
OTHER	breathing exercises	Initially, pre-test data were collected from both the intervention and control groups using the measurement instruments prior to the commencement of the exercise program. Subsequently, the intervention group underwent an eight-week exercise program using an incentive spirometer (Triflow) provided by the researchers. Patients were each given the same brand and model of Triflow device (manufactured in Turkey). Practical training on the use of the Triflow was provided, and visual materials prepared by the researcher were given to the patients. Exercise training was administered to the patients in the Chest Diseases Outpatient Clinic by the second author. Patients were instructed to perform the exercise hourly, 10 times per repetition, after waking up at home \[14\]. The breathing exercise program was evaluated weekly via telephone calls with the patients. No changes were made to the patients' inhaler treatments during the study period.

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-10-01
• Completion: 2023-10-30
• First posted: 2026-03-16
• Last updated: 2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)